MP87-19 EFFECT OF ABIRATERONE ACETATE AND LOW DOSE PREDNISONE ON PROSTATE-SPECIFIC ANTIGEN IN PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: THE RESULTS FROM IMPACT OF ABIRATERONE ACETATE IN PROSTATE-SPECIFIC ANTIGEN CORE STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced III1 Apr 2015MP87-19 EFFECT OF ABIRATERONE ACETATE AND LOW DOSE PREDNISONE ON PROSTATE-SPECIFIC ANTIGEN IN PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: THE RESULTS FROM IMPACT OF ABIRATERONE ACETATE IN PROSTATE-SPECIFIC ANTIGEN CORE STUDY Charles J. Ryan, E. David Crawford, Neal D. Shore, Willie Underwood, Jim Wang, Jannell DePalantino, Anil Londhe, Zane Yang, Shawn Black, Tracy McGowan, and Philip W. Kantoff Charles J. RyanCharles J. Ryan More articles by this author , E. David CrawfordE. David Crawford More articles by this author , Neal D. ShoreNeal D. Shore More articles by this author , Willie UnderwoodWillie Underwood More articles by this author , Jim WangJim Wang More articles by this author , Jannell DePalantinoJannell DePalantino More articles by this author , Anil LondheAnil Londhe More articles by this author , Zane YangZane Yang More articles by this author , Shawn BlackShawn Black More articles by this author , Tracy McGowanTracy McGowan More articles by this author , and Philip W. KantoffPhilip W. Kantoff More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1964AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patients with non-metastatic CRPC (nmCRPC) will eventually progress to mCRPC. Currently there is no approved therapy for nmCRPC. This phase II, multi-center study evaluated the ability of abiraterone acetate (AA) plus 5 mg of prednisone to decrease PSA levels in patients with nmCRPC and rising PSA. METHODS All patients had nmCRPC but with clinical features placing them at higher risk of developing mCRPC: PSA value ≥ 10ng/mL or PSA doubling time ≤ 10 months at screening. Patients received AA 1000mg with P 5mg (AA+P5) daily; each treatment cycle=28 days. The primary endpoint was PSA response rate at 6 months. Key secondary endpoints included change in testosterone levels, time to PSA progression, time to radiographic disease progression, and safety. PSA assessment and imaging scans were conducted every 3 months. RESULTS From May 2011 to July 2013, 131 patients were enrolled at 38 sites in the US. Data cutoff for this analysis was December 31, 2013. Median age was 72 years (range 48-90). Median baseline PSA was 11.9ng/mL (range 1.3-167.8ng/mL). There were 122 patients evaluable for the analysis of PSA response. By the end of 6 cycles of treatment, 87% (106/122) of patients had ≥ 50% reduction in PSA and 60% (73/122) had ≥ 90% PSA reduction. 23 patients (17.6%) experienced PSA progression. PSA progression-free rates at 12, 18, and 24 months were estimated at 82.4%, 73.5%, and 62.8%, respectively. Median time to PSA progression was not estimable at the time of data cut off. Radiographic progression-free survival rates at 12, 18, and 24 months were 89, 87, and 87, respectively. Mean testosterone levels were reduced by approximately 96% after 3 and 6 cycles of study treatment. 92.4% of patients had an adverse event (AE) (43.6% had a Grade 3 or higher) and 29.0% had a serious AE (27.5% had a serious AE of Grade 3 or higher). 10.7% of patients had AEs resulting in discontinuation of study treatment. Four patients had AEs resulting in death: coronary artery disease, myocardial infarction, acute respiratory failure, and pneumonia. To date, no patient has had his prednisone dose increased to greater than 5mg to manage symptoms of mineralocorticoid excess. CONCLUSIONS In men with high-risk nmCRPC, treatment using AA+P5 is very effective in lowering PSA. The rate and depth of PSA decline appear superior to men with mCRPC. The safety profile in this trial using prednisone 5 mg is consistent with previously reported data using 10mg prednisone daily. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1091 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Charles J. Ryan More articles by this author E. David Crawford More articles by this author Neal D. Shore More articles by this author Willie Underwood More articles by this author Jim Wang More articles by this author Jannell DePalantino More articles by this author Anil Londhe More articles by this author Zane Yang More articles by this author Shawn Black More articles by this author Tracy McGowan More articles by this author Philip W. Kantoff More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...